F&P Airvo 3— 510(k) K221338

Substantially Equivalent

Fisher & Paykel Healthcare

FDA 510(k) clearance K221338 for F&P Airvo 3, Substantially Equivalent on 2023-01-27. Applicant: Fisher & Paykel Healthcare.

Clearance details

Applicant: Fisher & Paykel Healthcare
Product code: Code QAV
Advisory panel: Anesthesiology
Date received: 2022-05-09
Decision date: 2023-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manukau, NZ

Download summary PDF View on FDA.gov ↗

Adverse events under product code QAV

product code QAV

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.